Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K960159 |
Device Name |
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS) |
Applicant |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
STEPHEN M ENOS |
Correspondent |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
STEPHEN M ENOS |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 01/11/1996 |
Decision Date | 10/25/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|